Endovenous Lidocaine and Serum Cytokines Concentration

NCT02363699 | Completed Phase 4

• 1 other identifier: LIDOCAINE X CYTOCINES
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ineffective treatment of postoperative pain may cause organic damage and chronic pain. Nevertheless, opioids, the leading drugs used for this purpose, present side effects that sometimes restrict their usability. In a multimodal context, new postoperative analgesia techniques have been developed focusing in the reduction of opioid use and their adverse effects, as well as postoperative chronic pain prevention. In this background, continuous intravenous infusion of lidocaine during perioperative period has shown to be promising. This trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a control group. Intravenous lidocaine in the perioperative period of laparoscopic cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by the significant changes in the studied cytokines.

Conditions

Cholelithiasis

Keywords

cholelithiasis; Cytokines; under general anesthesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores

  The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.

  24 hours

Secondary Outcomes (5)

• The secondary outcome was measure of citokynes IL-1 levels

  24 hours.

• The secondary outcome was measure of citokynes IL-6 levels

  24 hours

• The secondary outcome was measure of citokynes IL-10 levels

  24 hours

• The secondary outcome was measure of citokynes TNF levels

  24 hours

• The secondary outcome was measure of citokynes IFN γ levels

  24 hours

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Group treated with lidocaine solution

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Group treated with saline solution

Drug: Saline solution

Interventions

Lidocaine DRUG

Lidocaine was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure. Solution of 0,3% lidocaine was used, so that the infusion rate was equal to the weight of the patient.

Also known as: Xilocayne, Lidocaine hydrochloride

Lidocaine

Saline solution DRUG

Saline solution was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years and
• physical status according to the American Society of Anesthesiologists (ASA) I and II

You may not qualify if:

• patients older than 75 years,
• patients with heart disease,
• patients with history of:
• kidney failure,
• liver failure,
• psychiatric disorder,
• chronic use of opioids or medications that could cause induction of liver enzymes (anticonvulsants).
• the presentation of adverse effects during the intervention or postoperative complications, and the conversion to open surgery.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead
• Universidade Federal de Santa Catarina: collaborator

MeSH Terms

Conditions

Cholelithiasis

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Juliano Ferreira, PhD

  Federal University of Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 16, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 16, 2015

Record last verified: 2015-02